DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
The Response filed July 20, 2026 has been entered. Claims 1-6, 8-13, and 15-25 are pending in the application. Response to applicant's arguments can be found at the end of this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 20, 2026 was filed after the mailing date of the non-final Office Action on June 9, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 8-13, 15-22, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Berrada et al. (U.S. Patent No. 8956384; hereinafter “Berrada”) in view of Salahieh et al. (U.S. Patent No. 7648518; hereinafter “Salahieh”).
Regarding claim 1, Berrada discloses a material capture system (Figs. 16-20B) comprising:
a first shaft (102) defining a central lumen and a central longitudinal axis;
a second shaft (104) configured to be positioned within the central lumen of the first shaft; and
a body (70) defining a first end and a second end,
wherein the first end of the body defines an opening (112),
wherein the second end of the body is attached to the second shaft such that the second end of the body moves relative to the opening via movement of the second shaft relative to the first shaft (col. 24, ll. 48-51), and
wherein the body is configured to be transformed from a compressed configuration to an expanded configuration in which the first end is expanded and the opening defines a radial center offset from the central longitudinal axis (Figs. 16-17; col. 24, ll. 31-47), and
wherein movement of the second shaft distally relative to the first shaft causes an expanded portion of the body to elongate (col. 24, ll. 48-54).
The device of Berrada discloses the invention substantially as claimed, except for a tapered nose tip coupled to a distalmost end of the second shaft. However, Berrada teaches providing the system with a safety tip (95) positioned distal of the body in an expanded configuration (Fig. 3F).
Salahieh, a reference in the embolic filter device field of endeavor, teaches providing a material capture system (Figs. 5A-5C) with a tapered nose tip (84) coupled to a distalmost end of a shaft (90); wherein in the expanded configuration of the a material capture body (80), the tapered nose tip is distal of the body (Fig. 5C), and wherein the shaft and the tapered nose tip define a guidewire lumen through which the shaft and the tapered nose tip are configured to receive a guidewire (12; Figs. 5B-5C), in order to facilitate atraumatic tracking of the system over the guidewire within a patient (col. 12, ll. 32-36).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the system of Berrada with a tapered nose tip coupled to a distalmost end of the second shaft; wherein in the expanded configuration of the body, the tapered nose tip is distal of the body, and wherein the second shaft and the tapered nose tip define a guidewire lumen through which the second shaft and the tapered nose tip are configured to receive a guidewire, in view of Salahieh, in order to mitigate the risk of harming a patient during advancement of the material capture system within the patient.
Regarding claim 2, Berrada discloses wherein the second end of the body is fixedly attached to the second shaft (Figs. 3A-3F).
Regarding claim 3, Berrada discloses wherein the second end of the body is attached to an outer surface of the second shaft (Figs. 3A-3F).
Regarding claim 4, Berrada discloses wherein when the body is in the expanded configuration, the second end is compressed (e.g., following the shape for filter body eversion; Fig. 16).
Regarding claim 5, Berrada discloses wherein movement of the second shaft distally relative to the first shaft causes the second end of the body to move distally relative to the opening (Figs. 16-17; col. 24, ll. 48-54).
Regarding claim 6, Berrada discloses wherein movement of the second shaft proximally relative to the first shaft causes the second end of the body to move proximally relative to the opening (Figs. 16-17; col. 24, ll. 24-54).
Regarding claim 8, Berrada discloses wherein movement of the second shaft proximally relative to the first shaft causes the expanded portion of the body to shorten (col. 24, ll. 24-54; see also col. 25, ll. 8-10).
Regarding claim 9, Berrada discloses wherein the central longitudinal axis of the first shaft extends through a perimeter of the opening of the body (e.g., the central longitudinal axis of shaft (102) extends through material of filter body (70) defining the edge of opening (112); Figs. 16-17).
Regarding claim 10, Berrada discloses wherein the perimeter of the opening is attached to the first shaft (Figs. 16-17).
Regarding claim 11, Berrada discloses a material capture system (Figs. 16-20B) comprising:
a first shaft (102) defining a central lumen and a central longitudinal axis;
a second shaft (104) configured to be positioned within the central lumen of the first shaft; and
a body (70) defining a first end and a second end,
wherein the first end of the body defines an opening (112),
wherein the second end of the body is fixedly attached to an outer surface of the second shaft (Figs. 3A-3F) such that the second end of the body moves distally relative to the opening via movement of the second shaft relative to the first shaft (col. 24, ll. 48-51), and
wherein the body is configured to be transformed from a compressed configuration to an expanded configuration in which the first end is expanded and the opening defines a radial center offset from the central longitudinal axis (Figs. 16-17; col. 24, ll. 31-47), and
wherein movement of the second shaft distally relative to the first shaft causes an expanded portion of the body to elongate (col. 24, ll. 48-54).
The device of Berrada discloses the invention substantially as claimed, except for a tapered nose tip coupled to a distalmost end of the second shaft. However, Berrada teaches providing the system with a safety tip (95) positioned distal of the body in an expanded configuration (Fig. 3F).
Salahieh, a reference in the embolic filter device field of endeavor, teaches providing a material capture system (Figs. 5A-5C) with a tapered nose tip (84) coupled to a distalmost end of a shaft (90); wherein in the expanded configuration of the a material capture body (80), the tapered nose tip is distal of the body (Fig. 5C), and wherein the shaft and the tapered nose tip define a guidewire lumen through which the shaft and the tapered nose tip are configured to receive a guidewire (12; Figs. 5B-5C), in order to facilitate atraumatic tracking of the system over the guidewire within a patient (col. 12, ll. 32-36).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the system of Berrada with a tapered nose tip coupled to a distalmost end of the second shaft; wherein in the expanded configuration of the body, the tapered nose tip is distal of the body, and wherein the second shaft and the tapered nose tip define a guidewire lumen through which the second shaft and the tapered nose tip are configured to receive a guidewire, in view of Salahieh, in order to mitigate the risk of harming a patient during advancement of the material capture system within the patient.
Regarding claim 12, Berrada discloses wherein when the body is in the expanded configuration, the second end is compressed (e.g., following the shape for filter body eversion; Fig. 16).
Regarding claim 13, Berrada discloses wherein movement of the second shaft proximally relative to the first shaft causes the second end of the body to move proximally relative to the opening (Figs. 16-17; col. 24, ll. 24-54).
Regarding claim 15, Berrada discloses wherein the central longitudinal axis of the first shaft extends through a perimeter of the opening of the body (e.g., the central longitudinal axis of shaft (102) extends through material of filter body (70) defining the edge of opening (112); Figs. 16-17).
Regarding claim 16, Berrada discloses a method comprising:
positioning a material capture system near an obstruction (362; Fig. 16), the material capture system comprising:
a first shaft (102) defining a central lumen and a central longitudinal axis;
a second shaft (104) configured to be positioned within the central lumen of the first shaft; and
a body (70) defining a first end and a second end,
wherein the first end of the body defines an opening (112), and
wherein the second end of the body is attached to the second shaft such that the second end of the body moves relative to the opening via movement of the second shaft relative to the first shaft (col. 24, ll. 48-51), and
wherein movement of the second shaft distally relative to the first shaft causes an expanded portion of the body to elongate (col. 24, ll. 48-54); and
transforming the material capture system from a compressed configuration into an expanded configuration, for capturing the obstruction, in which the first end is expanded and the opening defines a radial center offset from the central longitudinal axis (Figs. 16-17; col. 24, ll. 31-47; see also col. 25, ll. 25-41).
The method of Berrada discloses the invention substantially as claimed, except for the material capture system including a tapered nose tip coupled to a distalmost end of the second shaft. However, Berrada teaches providing the system with a safety tip (95) positioned distal of the body in an expanded configuration (Fig. 3F).
Salahieh, a reference in the embolic filter device field of endeavor, teaches providing a material capture system (Figs. 5A-5C) with a tapered nose tip (84) coupled to a distalmost end of a shaft (90); wherein in the expanded configuration of the a material capture body (80), the tapered nose tip is distal of the body (Fig. 5C), and wherein the shaft and the tapered nose tip define a guidewire lumen through which the shaft and the tapered nose tip are configured to receive a guidewire (12; Figs. 5B-5C), in order to facilitate atraumatic tracking of the system over the guidewire within a patient (col. 12, ll. 32-36).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the material capture system of Berrada with a tapered nose tip coupled to a distalmost end of the second shaft; wherein in the expanded configuration of the body, the tapered nose tip is distal of the body, and wherein the second shaft and the tapered nose tip define a guidewire lumen through which the second shaft and the tapered nose tip are configured to receive a guidewire, in view of Salahieh, in order to mitigate the risk of harming a patient during advancement of the material capture system within the patient.
Regarding claim 17, Berrada discloses wherein the second end of the body is fixedly attached to the second shaft (Figs. 3A-3F).
Regarding claim 18, Berrada discloses wherein the second end of the body is attached to an outer surface of the second shaft (Figs. 3A-3F).
Regarding claim 19, Berrada discloses wherein movement of the second shaft distally relative to the first shaft causes the second end of the body to move distally relative to the opening (Figs. 16-17; col. 24, ll. 48-54).
Regarding claim 20, Berrada discloses wherein the central longitudinal axis of the first shaft extends through a perimeter of the opening of the body (e.g., the central longitudinal axis of shaft (102) extends through material of filter body (70) defining the edge of opening (112); Figs. 16-17).
Regarding claim 21, Berrada discloses a material capture system comprising:
a first shaft (102) defining a central lumen and a central longitudinal axis;
a second shaft (104) configured to be positioned within the central lumen of the first shaft; and
a body (70) defining a first end and a second end,
wherein the first end of the body defines an opening (112),
wherein the second end of the body is attached to the second shaft such that the second end of the body moves relative to the opening via movement of the second shaft relative to the first shaft (col. 24, ll. 48-51),
wherein the body is configured to be transformed from a compressed configuration to an expanded configuration in which the first end is expanded and the opening defines a radial center offset from the central longitudinal axis (Figs. 16-17; col. 24, ll. 31-47), and
wherein movement of the second shaft proximally relative to the first shaft causes an expanded portion of the body to shorten (col. 24, ll. 24-54; see also col. 25, ll. 8-10).
The device of Berrada discloses the invention substantially as claimed, except for a tapered nose tip coupled to a distalmost end of the second shaft. However, Berrada teaches providing the system with a safety tip (95) positioned distal of the body in an expanded configuration (Fig. 3F).
Salahieh, a reference in the embolic filter device field of endeavor, teaches providing a material capture system (Figs. 5A-5C) with a tapered nose tip (84) coupled to a distalmost end of a shaft (90); wherein in the expanded configuration of the a material capture body (80), the tapered nose tip is distal of the body (Fig. 5C), and wherein the shaft and the tapered nose tip define a guidewire lumen through which the shaft and the tapered nose tip are configured to receive a guidewire (12; Figs. 5B-5C), in order to facilitate atraumatic tracking of the system over the guidewire within a patient (col. 12, ll. 32-36).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the system of Berrada with a tapered nose tip coupled to a distalmost end of the second shaft; wherein in the expanded configuration of the body, the tapered nose tip is distal of the body, and wherein the second shaft and the tapered nose tip define a guidewire lumen through which the second shaft and the tapered nose tip are configured to receive a guidewire, in view of Salahieh, in order to mitigate the risk of harming a patient during advancement of the material capture system within the patient.
Regarding claim 22, which depends from claim 1, Berrada discloses the system further comprising an outer sheath (delivery tube; col. 24, ll. 44-47). Berrada further discloses the delivery tube (202) having a distal end and configured to receive the first shaft, the second shaft, and the body (Fig. 8A; col. 16, ll. 49-54).
The device of Berrada discloses the invention substantially as claimed, except for wherein the outer sheath comprises a radiopaque marker at the distal end of the outer sheath.
Salahieh teaches that a radiopaque element located at the distal end of a delivery sheath (32) facilitates delivering and deploying a material capture system within a patient (col. 16, ll. 29-33; see also col. 14, ll. 47-51).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the outer sheath with a radiopaque marker at the distal end of the outer sheath, in view of Salahieh, in order to allow for imaging of the system within a patient to facilitate accurate positioning at a treatment site within a patient.
Regarding claim 24, which depends from claim 1, Berrada discloses the system further comprising a radially expanded capture guide (364), the capture guide including a proximal portion (loop; Figs. 16-17) and a distal portion (portion threaded at location (365); Fig. 16), wherein the proximal portion of the capture guide forms a loop and is secured to a perimeter of the opening of the body (Figs. 16-17; col. 24, ll. 31-47), wherein the proximal portion of the capture guide includes at least one linear segment (portion of loop (364) positioned under proximal ring (126; Fig. 16; see also Fig. 4C) extending proximally from the distal portion, the linear segment being secured to an outer wall of the first shaft (e.g., secured by proximal ring (126) onto first shaft (102); Fig. 4C; col. 14, ll. 30-50).
Regarding claim 25, which depends from claim 1, the modified device discloses the invention substantially as claimed, except for the distalmost end of the second shaft being distal to the body in compressed and expanded configurations.
Salahieh teaches configuring an inner shaft (90) carrying nose cone (84) to have a distalmost end that is distal to a material capture body (82) when the body is in a compressed configuration (Fig. 5B) and when the body is in the expanded configuration (Fig. 5C) to position the nose cone to facilitate atraumatic tracking of the system over a guidewire within a patient (col. 12, ll. 32-36).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to connect the second shaft to the body such that the distalmost end of the second shaft is distal to the body when the body is in the compressed configuration and when the body is in the expanded configuration, in view of Salahieh, in order to mitigate the risk of harming a patient during advancement of the material capture system within the patient.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Berrada in view of Salahieh, as applied to claim 22 above, and further in view of Boyle et al. (U.S. Patent No. 7678128; hereinafter “Boyle”).
Regarding claim 23, the modified device discloses the invention substantially as claimed, except for the system including an expanding catheter.
Boyle, a reference in the embolic filter device field of endeavor, teaches providing a system with an expanding catheter (62; Figs. 4-5) configured to be positioned coaxially relative to an embolic capture system (Figs. 1-2), the expanding catheter having a polymer shaft (74; Figs. 4-5; col. 9, ll. 10-19 and col. 10, ll. 15-36) and an expandable funnel tip (64; Figs. 4-5; col. 9, ll. 45-50), the polymer shaft and the expandable funnel tip configured to receive the embolic capture system (Figs. 1-2). Boyle teaches that such an expanding catheter facilitates recovery of a filter body from within a patient without re-releasing trapped material (col. 4, ll. 44-57).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the modified system with an expanding catheter configured to be positioned coaxially relative to the outer sheath, the expanding catheter having a polymer shaft and an expandable funnel tip, the polymer shaft and the expandable funnel tip configured to receive the first shaft, the second shaft, and the body, in view of Boyle, in order to facilitate recovering the body after material has been collected therein without re-releasing the material.
Response to Arguments
Applicant’s arguments with respect to claims 1-6, 8-13, and 15-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
